HypertensionNCT01742923
Tailored Intervention to Improve Medication Adherence in Patients With Hypertension
A study testing Complex tailored intervention in people with Hypertension, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Patients with hypertension have an increased risk of stroke and myocardial infarction. However, poor adherence to treatment with antihypertensives and lipid-lowering agents occurs frequently within this patient group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Complex tailored intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 532 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years or older
- Patients receiving ambulatory treatment for hypertension in a hospital setting
- The patient or a carer usually dispenses the patient's medications
- Patient lives in the Southern Region of Denmark
- Written consent
Who cannot join
- Lives in a care home or institution
- Receive dose dispensed medicine from a pharmacy
- Medicine is dispensed by a nurse in the patient's home
- Correctional mental health patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacist Intervention Programme in Secondary Care to Improve Medication Adherence in Patients With Hypertension
Patients with hypertension have an increased risk of stroke and myocardial infarction. However, poor adherence to treatment with antihypertensives and lipid-lowering agents occurs frequently within this patient group. The purpose of this study is to investigate whether a complex tailored intervention in a hospital setting will lead to increased medication adherence and fewer cardiovascular events when compared to a usual care group. Interventions focus on motivational interviewing, medication review and telephone follow up.
- Conditions
- Hypertension
- Being tested
- Complex tailored intervention, Usual care
- Keywords
- hypertension, medication adherence, motivational interviewing
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex tailored interventionBehavioural
Usual careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Placebo comparator | Usual care Receives: Behavioral: Usual care |
| Complex tailored intervention | Experimental | The interventions consists of 3 elements:
1. Medication review with recommendations focused on antihypertensives and statins and adherence to guidelines and patient´s adherence to medications
2. Consultation with a pharmacist using motivational interviewing techniques
3. Follow-up telephone calls one month and six months after inclusion Receives: Behavioral: Complex tailored intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients that are at least 80% adherent (Medication possession rate > 0.8) to antihypertensives and statins
Measured: One year from inclusion
Secondary outcomes (3)
Non-persistence with antihypertensives and statins measured by percent of patients that are not supplied with medications for more than three continuous months
Measured: One year from inclusion
Reduction in systolic and diastolic blood pressure
Measured: One year from inclusion
Composite endpoint (stroke, myocardial infarction or cardiovascular death)
Measured: One year from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Ulla Hedegaard, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742923
- Sponsor's protocol ID
- AKF-384
- Status last verified
- Nov 2015
- First submitted
- 4 Dec 2012
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hedegaard U, Kjeldsen LJ, Pottegard A, Henriksen JE, Lambrechtsen J, Hangaard J, Hallas J. Improving Medication Adherence in Patients with Hypertension: A Randomized Trial. Am J Med. 2015 Dec;128(12):1351-61. doi: 10.1016/j.amjmed.2015.08.011. Epub 2015 Aug 21.
PubMed 26302142Hedegaard U, Hallas J, Ravn-Nielsen LV, Kjeldsen LJ. Process- and patient-reported outcomes of a multifaceted medication adherence intervention for hypertensive patients in secondary care. Res Social Adm Pharm. 2016 Mar-Apr;12(2):302-18. doi: 10.1016/j.sapharm.2015.05.006. Epub 2015 May 18.
PubMed 26088274
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist Intervention Programme in Secondary Care to Improve Medication Adherence in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT01742923
- Acronym / sponsor ID
- AKF-384
- Conditions
- Hypertension
- Keywords
- hypertension, medication adherence, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with hypertension have an increased risk of stroke and myocardial infarction. However, poor adherence to treatment with antihypertensives and lipid-lowering agents occurs frequently within this patient group. The purpose of this study is to investigate whether a complex tailored intervention in a hospital setting will lead to increased medication adherence and fewer cardiovascular events when compared to a usual care group. Interventions focus on motivational interviewing, medication review and telephone follow up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Placebo comparator | Behavioral: Usual careUsual care |
| Complex tailored intervention | Experimental | Behavioral: Complex tailored interventionThe interventions consists of 3 elements: 1. Medication review with recommendations focused on antihypertensives and statins and adherence to guidelines and patient´s adherence to medications 2. Consultation with a pharmacist using motivational interviewing techniques 3. Follow-up telephone calls one month and six months after inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 years or older
- Patients receiving ambulatory treatment for hypertension in a hospital setting
- The patient or a carer usually dispenses the patient's medications
- Patient lives in the Southern Region of Denmark
- Written consent
Key exclusion criteria (4 listed)
- Lives in a care home or institution
- Receive dose dispensed medicine from a pharmacy
- Medicine is dispensed by a nurse in the patient's home
- Correctional mental health patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex tailored intervention | Behavioural | Complex tailored intervention |
| Usual care | Behavioural | Usual care |
Primary outcome
Percent of patients that are at least 80% adherent (Medication possession rate > 0.8) to antihypertensives and statins
Time frame: One year from inclusion
3 secondary outcomes
Non-persistence with antihypertensives and statins measured by percent of patients that are not supplied with medications for more than three continuous months
Time frame: One year from inclusion
Reduction in systolic and diastolic blood pressure
Time frame: One year from inclusion
Composite endpoint (stroke, myocardial infarction or cardiovascular death)
Time frame: One year from inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
- Results publication: PubMed 26302142Hedegaard U, Kjeldsen LJ, Pottegard A, Henriksen JE, Lambrechtsen J, Hangaard J, Hallas J. Improving Medication Adherence in Patients with Hypertension: A Randomized Trial. Am J Med. 2015 Dec;128(12):1351-61. doi: 10.1016/j.amjmed.2015.08.011. Epub 2015 Aug 21.
- Results publication: PubMed 26088274Hedegaard U, Hallas J, Ravn-Nielsen LV, Kjeldsen LJ. Process- and patient-reported outcomes of a multifaceted medication adherence intervention for hypertensive patients in secondary care. Res Social Adm Pharm. 2016 Mar-Apr;12(2):302-18. doi: 10.1016/j.sapharm.2015.05.006. Epub 2015 May 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex tailored intervention in people with Hypertension, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients that are at least 80% adherent (Medication possession rate > 0.8) to antihypertensives and statins (time frame: One year from inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01742923, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.